Back to resultsComparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Test Contact Lens
Control Contact Lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
- Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- Has an astigmatism of ≤ 1.00 D in subjective refraction;
- Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
- Demonstrates an acceptable fit with the study lenses;
- Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria:
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Ocular Research & Education;
- Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
- Has participated in any clinical trials within a week prior to the study.
Sites / Locations
- University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Contact lens
Control Contact Lens
Arm Description
Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
Outcomes
Primary Outcome Measures
Overall Lens Fit Acceptance
Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
Secondary Outcome Measures
Lens Centration
Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Lens Centration
Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Push-up Tightness
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Push-up Tightness
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04492397
Brief Title
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
Official Title
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each
Detailed Description
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Contact lens
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
Arm Title
Control Contact Lens
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
Intervention Type
Device
Intervention Name(s)
Test Contact Lens
Other Intervention Name(s)
stenfilcon A
Intervention Description
Subjects will be randomized to wear test lenses.
Intervention Type
Device
Intervention Name(s)
Control Contact Lens
Other Intervention Name(s)
verofilcon A
Intervention Description
Subjects will be randomized to wear control lenses.
Primary Outcome Measure Information:
Title
Overall Lens Fit Acceptance
Description
Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Lens Centration
Description
Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Time Frame
Baseline
Title
Lens Centration
Description
Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Time Frame
1 week
Title
Post-blink Movement
Description
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time Frame
Baseline
Title
Post-blink Movement
Description
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time Frame
1 week
Title
Push-up Tightness
Description
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Time Frame
Baseline
Title
Push-up Tightness
Description
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
Has an astigmatism of ≤ 1.00 D in subjective refraction;
Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
Demonstrates an acceptable fit with the study lenses;
Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria:
Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
Is aphakic;
Has undergone refractive error surgery;
Is an employee of the Centre for Ocular Research & Education;
Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
Has participated in any clinical trials within a week prior to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCOptom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
We'll reach out to this number within 24 hrs